Delivering Uninterrupted Care Under COVID-19

Healthcare Medication Supply Problems

The pervasive effects of COVID-19 are being felt by everyone, and no industry has been untouched. As the sum of infected climbed, resources became increasingly scarce. While there are a number of medications supporting viable treatment options and personal protective equipment (PPE) known to mitigate transmission, these resources are in short supply.

As healthcare workers fight on the front lines to save lives, supply chain faces a battle of its own with skyrocketing demand.

A National Emergency

The Declaration of a National Emergency in mid-March motivated several medical associations, including the CDC, to recommend the cancellation or postponement of all elective surgical procedures. As elective surgeries are rescheduled and surgery centers and clinics start to reopen, the impact has been substantial.

Shelter-in-place orders have led to increased cancellations and no-shows for specialty physicians whose services are not immediately necessary. As a result, many hospitals, surgery centers and physician groups are in dire financial straits. Decreased revenue is creating a snowball effect.

West TN Healthcare is said to have lost in excess of 18 million dollars from elective surgeries that were not performed, and facilities like Catholic Health in New York and Anne Arundel Medical Center in Maryland have each reportedly furloughed over a thousand workers (Becker’s Hospital CFO Report).

On a smaller scale, one anesthesia practice in Washington had two physicians retire early while having to cut 40% of their office staff.

“As soon as we stopped doing elective surgeries, our surgery load dropped down to about 20% of what it was before,” said Dr. Brian Nyquist, an anesthesiologist, and partner in the practice. “We pretty quickly realized within that first week how much trouble we were going to be in financially and as a group if we didn’t do something.”
- The Seattle Times

Difficulties in obtaining PPE’s and COVID-related drugs are being felt worldwide. However, there are suppliers who can help stabilize the industry and possibly reduce the burden to hospitals and other medical facilities.

Reliable Medication Resources in Times of Crisis and Beyond

Pharmacy Purchasing and Products, a buyer’s guide and best practices journal, provided a free educational webinar sponsored in part by Fagron Sterile Services US on Friday, May 1st. The presentation was designed to educate attendees about the benefits of working with a 503B Outsourcing Facility.

As the nation comes together to maneuver through the COVID-19 Pandemic, information and resources are actively being shared to assist on all fronts. This educational webinar for healthcare supply chain professionals and pharmacists outlines options to utilize 503B pharmaceutical outsourcing facilities to help address challenges brought on by COVID-19, drug shortage problems and more.

Lou Diorio, RPh, FAPhA

Mr. Diorio presents a much-needed solution for hospitals and pharmacies struggling with reliable supply in this time of crisis, and provides proactive/preventative ideas. Diorio, a pharmacist, hospital/health system consultant and featured speaker of the webinar states,

“The overwhelming and unprecedented challenges of COVID-19 require an evaluation of every opportunity we have to increase efficiency and lower risk in the pharmacy. Outsourced compounding is no exception. Possibilities for expanding [Compounded Sterile Preparation (CSP)] offerings, flexing staff assignments, and maximizing cleanroom resources are goals we all need to investigate.”

Diorio is Principal of LDT Health Solutions, Inc., an international medication safety and quality management consulting company with 12 years of experience. He is an adjunct professor of pharmacy practice and preceptor of pharmacy students at Long Island University’s Schwartz College of Pharmacy.

Diorio serves as a member of both the NY State Council of Health-System Pharmacists’ Research and Education Committee, as well as the New Jersey Society of Health System Pharmacists’ Industry Relations Committee. Both his credentials and experience near the epicenter of this pandemic grant Diorio unique insight.

Presentation Highlights

Listen Now & Download: Materials, FSS Product Catalog

Diorio briefly explains the regulatory environment for 503B’s, potential safety issues, and the vetting processes for both sterile and non-sterile compounded preparations. He asserts that outsourced compounding can provide multiple benefits such as:

• Offerings for Compounded Sterile-Preparations (CSPs) in both drugs and dosages are expanded

• Maximized cleanroom resources while allowing for more maneuverable staffing options

• Organizations may be able to decrease their cleanroom footprint by outsourcing some of the workload while potentially reallocating budget to support clinical staff

• Extended Beyond Use Date (BUD) capability and increased buying power to support hospital pharmacies, ambulatory surgery centers and clinics that encounter COVID related disruptions, such as drug shortages and drug waste can be offered by larger 503B’s

Staffing shortage is also a common problem that is made worse with an increased demand for compounding supply. Ready-to-administer doses acquired from outsourcing facilities bypass the compounding room giving organizations the ability to adapt to their circumstances.

503B’s are also monitored by numerous regulatory agencies which may offer peace-of-mind regarding quality and safety. The FDA, DEA, OSHA, and State Boards of Pharmacy are just a few organizations that are in place to monitor environmental conditions, labeling practices, and procedural processes. These organizations, among others, focus on bringing light to any insufficiencies with aseptic processing areas in addition to reviewing paperwork to ensure any deficiencies have been properly addressed.

Vetting a 503B Outsourcing Facility

Diorio encourages each healthcare organization to take an active role when vetting a new 503B outsourcing pharmacy (more appropriately referred to as a 503B outsourcing facility). There is shared responsibility when partnering with an outsourcer. He advises the issuance of a 483 form from the FDA should not automatically exclude an outsourcing facility from providing services. USP and government standards are constantly evolving and further investigation with definitive documentation is always needed regarding any corrective actions the group has taken.

Continual quality and operations reporting should also be established and followed up with regular reviews. Include specific key quality indicators that are important if their standard reports do not already include them.

Diorio proposes 503B outsourcing facilities can be a valuable resource as the fight against COVID-19 continues. With a little due diligence, providing uninterrupted care in hospitals, surgery centers, clinics and physician offices may be possible with a reliable 503B partnership.

A Solution You Can Rely On…

Fagron Sterile Services US (FSS), the title sponsor of the webinar, is a FDA/DEA registered and inspected 503B Outsourcer equipped with multiple facilities, industry leading automation, environmental monitoring, in-house quality testing labs and independent clean rooms – all state-of-the-art.

FSS offers a quality focused 503B outsourcing solution with independent ISO-5 classified aseptic processing environments for additional quality control. All this combined with decades of experience specializing in CSPs for acute care hospitals, ambulatory surgery centers and clinics help offer peace-of-mind to over 7,300 FSS customers and the patients they serve.

FSS also holds IDN agreements within all major GPO’s and some of the best turnaround times in the industry – 97% same-day fill-rate on orders placed before cut-off times!

View Fagron Sterile Services’ Full Product Catalog Here.